E25Bio COVID-19 Direct Antigen Rapid Test recall
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
Why was E25Bio COVID-19 Direct Antigen Rapid Test recalled?
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020
- Product
- E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
- Recalling firm
- E25Bio, Inc.
- Quantity
- 73,300 units
- Distribution
- US Nationwide distribution in the states of MA, FL, and HI.
- Recall date
- February 16, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)